WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced a voluntary recall by Boulla LLC of lot number 230811 of Boom Max capsules. These capsules, packaged in 10-count blisters within a black and red carton, were found to contain sildenafil, an active ingredient used in FDA-approved products for treating male erectile dysfunction. Sildenafil belongs to the family of drugs known as phosphodiesterase (PDE-5) inhibitors, which are not permitted in dietary supplements.
The presence of undeclared sildenafil poses significant health risks, particularly for individuals taking nitrates, such as nitroglycerin, typically prescribed for conditions like diabetes, hypertension, high cholesterol, or heart disease. The interaction between sildenafil and nitrates can lead to a dangerous drop in blood pressure, potentially resulting in life-threatening consequences. Adult males who use nitrates for cardiac conditions are especially at risk. However, Boulla LLC has not yet received any reports of adverse events related to this recall.
The recall involves Boom Max capsules distributed through the internet and fulfilled by Amazon nationwide in the United States. The product, marketed as a dietary supplement for male performance and energy, was identified by the lot number 230811 and ASIN B0D2PRLQ79. Consumers are advised to stop using Boom Max capsules from the affected lot immediately.
Boulla LLC is actively notifying its distributors and customers through public announcements and Amazon Messaging. The company is also arranging for the return of all recalled products. Consumers with the recalled Boom Max capsules should discontinue use and contact Boulla LLC for refund or disposal instructions.
For further information, consumers can reach out to John Tran at Boulla LLC via phone at 916-619-7926 or email at info@boullallc.com. The company’s customer service is available Monday through Friday from 9 AM to 5 PM PST. Additionally, consumers who have experienced any related health issues are urged to consult their healthcare provider.
The FDA emphasizes the importance of proper labeling, especially when it involves potential allergens or active pharmaceutical ingredients. Those who have experienced adverse reactions or quality problems with Boom Max capsules are encouraged to report these issues to the FDA’s MedWatch Adverse Event Reporting program.
The swift action by Boulla LLC and the FDA aims to protect public health by ensuring that only safe and properly labeled products are available to consumers.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.